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Immutep’s LAG‑3 gamble fails: stock plunges after Phase III futility
Immutep disclosed that an independent data monitoring committee recommended stopping the Phase III TACTI‑004 study of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer for futility....
Cadonilimab combo extends benefit in advanced cervical cancer – Phase III
COMPASSION‑16 Phase III results show cadonilimab combined with chemotherapy, with or without bevacizumab, improves outcomes as first‑line treatment for advanced cervical cancer, the sponsors...
Ultragenyx gene therapy clears key bar: late‑stage endpoint met in OTC study
Ultragenyx reported that its gene therapy candidate for ornithine transcarbamylase (OTC) deficiency met one of two primary endpoints in a Phase III trial, marking a pivotal clinical advance for a...
Sana cell therapy shows persistent insulin production: 14‑month follow‑up
Sana Biotechnology reported that an investigational allogeneic cell therapy continued producing insulin in a single Type 1 diabetes patient at 14‑month follow‑up with no new safety signals. The...
Senolytic strategy stalls pancreatic cancer’s growth in preclinical models – new avenue
Researchers reported that a senolytic therapeutic approach targeting senescent cells in the tumor microenvironment produced tumor control in preclinical pancreatic ductal adenocarcinoma (PDAC)...
Engineered bacteria break decades‑old doxorubicin bottleneck: scalable biosynthesis
An international team engineered a bacterial strain that overcomes long‑standing biosynthetic bottlenecks in doxorubicin production, the consortium reported in Nature Communications. The...
Src appears on tumor surfaces: antibody therapies gain a new target
UCSF scientists discovered extracellular membrane‑associated Src (eSrc) on the surface of multiple tumor types and demonstrated that antibodies targeting eSrc shrink tumors in mouse models, the...
Modular cytokine scaffold lengthens CAR‑T persistence – Science Advances
Researchers at Albert Einstein College of Medicine reported a manufacturing approach that uses a tricytokine fusion scaffold (IL‑7/IL‑15/IL‑21) to generate CAR‑T cells enriched for long‑lived T...
PSMA PET reduces need for prostate biopsies: PRIMARY2 shows diagnostic impact
The PRIMARY2 clinical trial demonstrated that PSMA PET/CT imaging can markedly lower the number of invasive prostate biopsies in men with suspected cancer after inconclusive or reassuring MRI, the...
FDA draft eases biosimilar testing: agency proposes lower barriers for approvals
The U.S. Food and Drug Administration issued draft guidance designed to simplify biosimilar development by allowing, in certain cases, reliance on comparator product data generated outside the...
Immutep’s LAG‑3 miss: Phase III stopped, stock tanks
Immutep disclosed that its Phase III TACTI‑004 trial of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer was halted for futility after an independent data monitoring committee...
Ultragenyx hits co‑primary endpoint: gene therapy advances in urea‑cycle disease
Ultragenyx reported that its AAV‑based gene therapy achieved one of two co‑primary endpoints in a Phase III study for ornithine transcarbamylase (OTC) deficiency, a rare urea cycle disorder. The...
FDA expands Arexvy label: GSK wins broader RSV clearance
The U.S. Food and Drug Administration granted broader clearance for GSK’s respiratory syncytial virus vaccine Arexvy, extending the labeled population and potential use cases for the shot. The...
China approves commercial BCI: Neuracle’s brain implant cleared for spinal‑injury use
Chinese regulators approved a coin‑sized, wireless brain‑computer interface (BCI) made by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries—the...
Cadonilimab combo: Phase III COMPASSION‑16 shows first‑line benefit in advanced cervical cancer
The COMPASSION‑16 Phase III trial reported that adding cadonilimab to first‑line chemotherapy—alone or with bevacizumab—improved outcomes in advanced cervical cancer. Trial investigators presented...
KRAS interception halts precancerous pancreatic lesions; senolytics show therapy promise
Two separate lines of pancreatic cancer research reported actionable advances. A University of Pennsylvania–led preclinical study demonstrated that early intervention with KRAS inhibitors can...
CAR‑T durability reengineered: cytokine scaffolds and manufacturing tweaks boost persistence
Academic teams reported manufacturing and molecular strategies that significantly extend CAR‑T cell persistence in preclinical models. Albert Einstein College of Medicine investigators described a...
Amino acid cocktail supercharges LNP delivery: improved in vivo mRNA and CRISPR efficacy
Researchers at the Biohub reported that co‑administering a tailored amino acid supplement dramatically improved lipid‑nanoparticle (LNP) uptake and performance for mRNA delivery and CRISPR editing...
Stryker hit by cyberattack: global internal systems disrupted, operations delayed
Stryker disclosed a cyberattack that disrupted internal Microsoft‑based systems worldwide, knocking out some business applications and delaying order processing and manufacturing activities. The...
Orphan drug boom meets FDA flexibility: $400B sales forecast alongside RDEP trial leeway
Evaluate’s 2026 Orphan Drugs Report projects global orphan drug sales surpassing $400 billion by 2032, driven by expanding portfolios at companies such as Johnson & Johnson and Vertex. The report...